Cervical Collar Device for Thyroid Disorders

Recruiting in Palo Alto (17 mi)

Overseen by Prasanna Santhanam, MBBS, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Cervical spine diseases, pregnancy, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The Collar Therapy Indicator (CoTI) (A device that is placed in collar around the neck resembling a turtle neck sweater collar with a wire and recording box) has been shown in a single small previously published experience to provide data regarding radioiodine exposure that correlates with conventional methods of measuring I-123 and I-131 uptakes after diagnostic dose administration and/or therapy for thyroid disorders. We hypothesize that the device's continuous measurement capability will permit more accurate estimates of radiation exposure to thyroid tissue than conventionally employed methods assessing fractional uptake at one or a few time points. It may also provide information about the extent of variability in the absorbed radiation dose among patients with thyroid cancer and hyperthyroidism. By providing more complete information about individual patient's exposures, it will facilitate more accurate estimation of the administered I-131 dose requirements for control of hyperthyroidism and thyroid remnant ablation while reducing the need for repeated visits to the clinic for dosimetry measurements. The aims of our project include the following: (1)To compare quantitative imaging-derived thyroid time activity curve to that obtained using the CoTI and to determine the extent to which there is variability in radiation dose predicted using conventional methods to that predicted from measurement of the full Time-Activity Curve (TAC).(2) Evaluate the uptake and clearance kinetics across the 5 patients in each category as proof of principle for a potential larger trial to investigate use of this device in optimizing the administered doses of radioactive iodine to achieve therapeutic goals while minimizing risks of comorbidities, such a post-radioiodine hypothyroidism in patients with Graves' disease.(3)Evaluate patient experience, convenience, and discomfort in using the CoTI device with a survey instrument.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the cervical collar device for thyroid disorders safe for humans?

The cervical collar device, known as the Collar Therapy Indicator (COTI), has been shown to be safe and feasible for monitoring radioactive iodine (RAI) therapy in patients with thyroid conditions. RAI is generally safe for treating hyperthyroidism and thyroid cancer, though it can lead to hypothyroidism (underactive thyroid) in some cases. ^{1 2 3 4 5}

How does the cervical collar device treatment for thyroid disorders differ from other treatments?

The cervical collar device, known as the Collar Therapy Indicator (COTI), is unique because it allows for real-time monitoring of radioactive iodine uptake in the thyroid, providing continuous data outside of a healthcare facility. This is different from traditional methods that typically require clinic visits and only provide data at one or two time points. ^{1 2 3 6 7}

Research Team

Prasanna Santhanam, MBBS, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for English-speaking individuals with Graves' disease confirmed by lab tests or those with intermediate/high-risk thyroid cancer needing radioiodine treatment. It's not suitable for pregnant women, the elderly, or anyone with certain cervical spine diseases.

Inclusion Criteria

I have a certain type of thyroid cancer needing specific treatment and can understand and follow instructions in English.

I have Graves' disease confirmed by tests and I understand and can follow instructions in English.

Exclusion Criteria

I have a condition affecting my neck's bones, like arthritis or wear and tear.

I am not pregnant, elderly, or unable to understand simple instructions.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radioiodine treatment and are monitored using the CoTI device for continuous radiation measurement

7 days

Multiple visits for imaging and device monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Data Collection and Analysis

Data on radioiodine uptake and patient experience with the CoTI device is collected and analyzed

6-9 months

Treatment Details

Interventions

• Cervical Collar Therapy Indicator (COTI) (Device)

Trial Overview The study is testing a neck collar device called CoTI that measures radiation exposure from radioiodine treatments in real-time. This could lead to more accurate doses of radioactive iodine and reduce clinic visits compared to current methods.

Participant Groups

Group I: Pilot Project Experimental Treatment 1 Intervention

It is a Pilot study of 10 persons

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

In a study of 93 patients with toxic nodular goiter, a higher dose of 740 MBq radioactive iodine (RAI) resulted in an 81% cure rate, significantly outperforming the 51% cure rate seen with a lower 370 MBq dose.

The higher dose also showed better efficacy in specific subgroups, curing 91% of patients with toxic adenoma and 76% of those with toxic multinodular goiter, although it was associated with a higher incidence of hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of low and high fixed dose radioactive iodine therapy in patients with toxic nodular goiter. Sonmez, B., Erem, C., Dogan, I., et al.[2011]

In a study of 40 pediatric patients treated with a fixed dose of radioactive iodine (RAI) for Graves' disease, all patients developed permanent hypothyroidism, typically within an average of 77 days after treatment.

The study indicates that while RAI is an effective treatment for Graves' disease in children, it consistently leads to hypothyroidism, and no specific predictive factors for the timing of this condition were identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course to hypothyroidism after fixed-dose radioablation therapy of Graves' disease in children. Nebesio, TD., Siddiqui, AR., Pescovitz, OH., et al.[2019]

A new method using a collar detector system (CoTI) combined with SPECT imaging allows for accurate measurement of I-131 uptake in the thyroid over 15 to 25 days, enabling personalized pharmacokinetics and absorbed dose calculations for patients undergoing therapy.

The method demonstrated significant differences in dynamic uptake profiles among patients, suggesting it may provide more precise dosimetry compared to traditional pretherapy measurements, which could enhance treatment outcomes and optimize therapeutic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method to measure the absorbed dose of the thyroid during I-131 therapy, using a collar detector system and a SPECT acquisition. van Gils, K., Brinks, P., Lavalaye, J., et al.[2018]

The study introduces a novel wearable device, the Collar Therapy Indicator (CoTI), which effectively measures the uptake of I-131 during radioiodine therapy, showing promise for improving treatment precision.

By providing real-time data on the biological half-life of iodine in individual patients, the CoTI could enhance the accuracy of radiation dose calculations and therapy evaluations, potentially leading to better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the actual I-131 thyroid uptake curve with a collar detector system: a feasibility study. Brinks, P., Van Gils, K., Kranenborg, E., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Real-time quantitation of thyroidal radioiodine uptake in thyroid disease with monitoring by a collar detection device. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Thyroid uptake test with portable device (COTI) after 131I tracer administration: proof of concept. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of low and high fixed dose radioactive iodine therapy in patients with toxic nodular goiter. [2011]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Radioactive iodine in low- to intermediate-risk papillary thyroid cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Time course to hypothyroidism after fixed-dose radioablation therapy of Graves' disease in children. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A method to measure the absorbed dose of the thyroid during I-131 therapy, using a collar detector system and a SPECT acquisition. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Measuring the actual I-131 thyroid uptake curve with a collar detector system: a feasibility study. [2023]